TissueTech raises $55m

TissueTech

TissueTech has raised approximately $55.3 million in a new round of equity financing, according to a recently posed SEC filing.

The Doral, Fla.-based company makes amniotic membrane- and umbilical cord-based products designed to treat ocular surface diseases (its Bio-Tissue subsidiary) and musculoskeletal conditions and wound care (its Amniox Medical business).

Money in the round came from three unnamed investors, with the first sale dated as having occurred on April 9, according to the filing.

The company is looking to raise an additional $27 million, which would bring the total raised up to approximately $82.3 million, according to the SEC filing.

TissueTech said that it plans to use a $10 million of the proceeds to repurchase from common stockholders on a pro rata basis, according to the SEC filing.

The company has not yet announced any other plans for the funds.

Admedus deals vaccines biz to Constellation Therapeutics

AdmedusAdmedus (ASX:AHZ) said today that it agreed to sell its vaccines business to Constellation Therapeutics in a deal that will see it own nearly 30% of the Chinese company.

Other shareholders in the vaccines would own another 11%, Queensland, Australia-based Admedus said. Sun Bright Holdings will own the remainder and put in $18 million until November 2022, in five $3.6 million installments pegged to “certain milestones,” the company said. Failure to pay an installment would trigger the conversion of 12% of Constellation shares to the Admedus bloc of vaccine business shareholders. Admedus CEO Wayne Patterson is slated to become chairman of Constellation Therapeutics as part of the transaction.

Last month Admedus won CE Mark approval in the European Union for its CardioCel 3D and VascuCel products.

Prellis Biologics raises $9m

Prellis Biologics

Prellis Biologics has raised $8.7 million in a new round of equity financing, according to a recently posed SEC filing.

The San Francisco-based company is developing ultra-fast high-resolution holographic laser printing technology intended for use in creating human organs and tissues, according to its website.

Prellis Biologics offers a number of products based around vascularized tissue structures and extracellular matrices intended to grow human tissues and cells, according to the site.

A total of 11 anonymous investors participated in the round, with the first date of sale noted as having occurred on March 12.

The company is looking to raise an additional $475,000 in the round which would bring the total raised up to $9.2 million, according to the SEC filing.

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Osiris shareholders sue to block $660m merger with Smith & Nephew

Smith & Nephew to acquires Osiris TherapeuticsA group of Osiris Therapeutics (NSDQ:OSIR) shareholders is suing to block its $660 million acquisition by Smith & Nephew (NYSE:SNN) because the purchase price is too low.

Earlier this month the British orthopedics and wound care giant put $19 per share on the table to acquire Osiris and its regenerative medicine portfolio, representing a 37% premium on the 90-day volume-weighted average for OSIR shares.

The deal is structured as a two-step tender offer, with Osiris chairman & co-founder Peter Friedli agreeing to commit his 30% stake. The acquisition is slated to close during the second quarter, with the 360 people employed by Osiris joining S&N, that company said. Osiris put up profit growth of 334.9% to $36.9 million last year, on sales growth of 20.5% to $142.8 million.

The lawsuit, brought by lead plaintiffs Elizabeth Recupero and Raymond Morrison in the U.S. District Court for Maryland against Friedli and fellow directors Thomas Knapp, Willi Miesch and Charles Reinhart III, alleges that the $19-per-share price “does not adequately reflect Osiris’s future growth prospects.” The suit disputes the calculation by Cantor Fitzgerald, which advised Osiris on the deal, saying that it’s based on revenue projections that are roughly half of the actual revenue growth from the prior four years.

“Over the prior four-year period, Osiris has grown revenues at 20%+ per year. At a valuation of $19.00 per share, Cantor Fitzgerald’s discounted cash flow analysis utilizes management’s projections which reflect revenue growth of just 10%, 10%, 9%, and 9% for 2019, 2020, 2021, and 2022, respectively,” according to the lawsuit. “Using Cantor Fitzgerald’s DCF model and the application of more appropriate revenue growth rates during the forecast period of 15% – 18%, (rather than 9%-10%) results in implied value per share of approximately $24.00, an increase of $5.00 per share over the offer price.”

That would make Osiris worth something more like $834 million.

The lawsuit seeks to block the merger “until such time that the individual defendants have adequately undertaken all appropriate and available methods to obtain a transaction which is in the best interests of Osiris’s stockholders,” according to the compliant.

Should the deal go through, the lawsuit asks the court to rescind the merger and award compensatory and rescissory damages. Either way the lawsuit wants the plaintiff’s legal costs to be covered by the defendants.

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PolarityTE reveals SEC investigation

PolarityTE

PolarityTE (NSDQ:PTE) this week revealed that it is the target of an SEC investigation into possible violations of federal securities laws.

The Salt Lake City, Utah-based company said that it received a copy of a formal order of investigation from the SEC on March 4, exploring possible violations of fraud and price manipulations, according to an SEC filing.

Read the whole story on our sister site, Drug Delivery Business News

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Admedus wins CE Mark for CardioCel 3D, VascuCel products

Admedus

Admedus (ASX:AHZ)  has won CE Mark approval in the European Union for its CardioCel 3D and VascuCel products which use its proprietary Adapt tissue technology, according to a report from ProactiveInvestors.

The Australian company plans to begin the first stage of a commercial launch of the devices in the region later this month, according to the report.

“After our initial positive experience with Adapt we are excited to have the choice of these 3D shaped products that will produce better reconstructions for complex aortic arch repair surgeries,” Dr. Tomasz Mroczek said, according to ProactiveInvestors.

“Obtaining CE Mark approval for the 3D portfolio is a further endorsement of the medical need and effectiveness of our 3D shaped collagen bioscaffold; a world first technology with proven anticalcification properties and zero DNA. Today’s approval of the 3D portfolio in Europe further reinforces the company’s focus on global strategic growth with geographic expansion into key markets and portfolio expansion of Adapt tissue technology products,” CEO Wayne Patterson said, according to the report. “The 3D single piece aortic valve is unique in the industry and forms the backbone of the company’s TAVR developmental project which has been expedited. We have now confirmed that human clinical trials will commence earlier than planned, and the development project has already generated great interest within the global medical community as the Adapt portfolio of products expand from mainly pediatric use to a wider patient population in the future.”

In June 2017, Admedus CEO Wayne Patterson spoke to MassDevice.com about his efforts to shift the company away from trends of overspending and towards profitability.

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Smith & Nephew puts up $660m for Osiris Therapeutics

Smith & Nephew to acquires Osiris TherapeuticsSmith & Nephew (NYSE:SNN) said today that it agreed to put $660 milli0on on the table to acquire Osiris Therapeutics (NSDQ:OSIR) and its regenerative medicine portfolio.

The British orthopedics and wound care giant said the $19-per-share deal is a 37% premium on the 90-day volume-weighted average for OSIR shares. It’s structured as a two-step tender offer, Smith & Nephew said, with Osiris chairman & co-founder Peter Friedli agreeing to commit his 30% stake. The acquisition is slated to close during the second quarter, with the 360 people employed by Osiris joining S&N, that company said.

“Greater presence in the fast-growing regenerative medicine market enhances our portfolio and will help immediately accelerate our wound management business as well as provide longer term innovations in additional channels and indications. We sought out a fast growing portfolio with strong clinical evidence addressing critical needs in the marketplace,” CEO Namal Nawana said in prepared remarks.

“I am immensely proud of the business we have built from our research into advanced regenerative technologies. Smith & Nephew is the best new owner to take these products forward, widening access to more customers and restoring quality of life for more patients,” Friedli added.

Osiris put up sales of $102 million for the nine months ended Sept. 30, 2018 and $36.5 million during last year’s third quarter. Fourth-quarter and full-year results are on tap for March 15, Smith & Nephew said.

The cash-and-debt transaction is expected to add to S&N’s adjusted earnings per share starting next year, with return on invested capital topping the cost of capital three years after closing, the company said.

OSIR shares closed up 0.9% at $18.88 each yesterday. SNN shares, which closed up 0.8% at $38.79, were up 0.7% to $39.04 apiece just before the open today.

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Cellect Biotechnology launches U.S. clinical trial

Cellect Biotechnology (NSDQ:APOP) said it is collaborating with Washington University on a study of its ApoGraft stem cell selection technology for bone marrow transplantations.

This will be the first clinical trial in the U.S. using Tel Aviv, Israel-based Cellect’s ApoGraft, which is designed to prevent acute graft-versus-host disease following bone marrow transplantation. The company previously reported positive safety and tolerability data from an ongoing trial that is being performed outside the U.S., and expects to report additional interim results during the first half of 2019.

Get the full story on our sister site, Medical Design & Outsourcing.

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Ortho RTi touts rotator cuff study results at conference

Startup Ortho Regenerative Technologies (CNSX:ORTH) said two new studies have validated its product’s ability to improve the repair of two distinct joint tissues – the rotator cuff tendon and articular cartilage.

The rotator cuff study results were presented yesterday at the Annual Orthopaedic Research Society meeting in Austin, Texas.

Get the full story on our sister site, Medical Design & Outsourcing.

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Tela Bio, Aroa Biosurgery win FDA nod for large-size OviTex bioscaffolds

Aroa Biosurgery, Tela Bio

Tela Bio and its partner Aroa Biosurgery said yesterday that it won FDA 510(k) clearance for large-size OviTex reinforced bioscaffolds intended for soft tissue repair.

The OviTex RBS devices are surgical implants with integrated biologic and synthetic materials to allow the movement of fluid and cells through the product, Malvern, Penn.-based Tela Bio said.

With the clearance, the companies said that they will now offer the OviTex RBS devices in the US in sizes up to 20×40 cm, a 150% surface area increase over its currently available offerings.

“We are pleased to launch larger OviTex RBSs as we continue our mission to provide valuable solutions for a full range of hernia repairs and abdominal wall reconstructions, including the most complex cases. Traditionally, large abdominal wall hernias can present a technical challenge for some surgeons. Our devices are now positioned to ensure that patients who are most at need have access to the most advanced technology to assist with their hernia repair,” Tela Bio prez & CEO Antony Koblish said in a prepared statement.

“The ability to cover a larger surface area could have many potential benefits for patients and surgeons in terms of securing the most complex hernia repairs properly and reducing the risk of recurrence. As a joint developer and the manufacturer of the Ovitex technology, it is encouraging to see growing demand and the continued expansion of our product portfolio. We provide a robust and comprehensive suite of accessible and affordable options that address the current shortcomings in surgical hernia repair solutions,” Aroa Biosurgery CEO Brian Ward said in a press release.

Last May, Tela Bio and Aroa Biosurgery said they won CE Mark approval in the European Union for the OviTex RBS, which Tela Bio commercially launched in the region.

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